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Anti-metabolites

Paclitaxel TPM for Cancer

Phase 1

Recruiting

Led By Carlos Chan, MD, PhD

Research Sponsored by Carlos Chan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Medically fit for surgery. Defined as: Patients who are able to undergo general anesthesia for abdominal surgery and have a metabolic equivalent (METs) ≥ 4

Have an ECOG performance of 0 to 2

Must not have

History of allergic reactions to paclitaxel, PLG co-polymer, mannitol, or polysorbate 80

Actively treated for other malignancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer treatment in patients who are not eligible for standard-of-care treatments.

Who is the study for?

This trial is for adults aged 18-75 with peritoneal carcinomatosis from specific cancers, who can't have standard treatments. They must understand the study and agree to participate, have measurable disease, be medically fit for surgery, and use effective contraception. Exclusions include inaccessible abdominal cavity due to prior surgery, uncontrolled illnesses, pregnancy or breastfeeding women, certain infections like HIV/Hepatitis B/C on treatment.

What is being tested?

The trial tests a new therapy using Paclitaxel-loaded microparticles designed to penetrate tumors in patients with peritoneal carcinomatosis. It's an early-phase study (phase I) focusing on people who don't qualify for existing treatment options.

What are the potential side effects?

Potential side effects may include allergic reactions similar to those seen with paclitaxel (a chemotherapy drug), such as nerve damage (neuropathy), blood disorders, liver issues reflected by enzyme levels in blood tests and possibly other unknown risks since it's a first-in-human study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fit for surgery and can handle general anesthesia.

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I can take care of myself and am up and about more than half of my waking hours.

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I have no other standard treatment options left.

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I am using a barrier method of contraception.

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I have or am suspected to have cancer spread in my abdomen from colorectal, ovarian, gastric, pancreatic, appendiceal cancer, or mesothelioma.

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I am between 18 and 75 years old.

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I have not had my uterus or both ovaries removed.

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My abdominal cancer can be measured by scans.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am allergic to paclitaxel, PLG, mannitol, or polysorbate 80.

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I am currently receiving treatment for another cancer.

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I haven't had chemotherapy or radiotherapy in the last 3 weeks and have recovered from any side effects.

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I have moderate to severe numbness, pain, or weakness in my hands or feet.

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I have HIV or Hepatitis B/C and am on antiretroviral therapy.

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I do not have any uncontrolled illnesses.

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My kidney function is very low.

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My surgeon says my abdomen is not suitable for surgery due to previous operations.

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My cancer has spread outside the peritoneal cavity.

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I have another active cancer besides non-melanoma skin cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assess safety of intraperitoneal Paclitaxel-loaded Tumor Penetrating Microparticles (TPM)

Determine the maximum tolerated dose (MTD) of intraperitoneal Paclitaxel-loaded Tumor Penetrating Microparticles (TPM)

Secondary study objectives

Assess potential therapeutic efficacy of intraperitoneal Paclitaxel-loaded Tumor Penetrating Microparticles (TPM)

Assess whether Paclitaxel-loaded Tumor Penetrating Microparticles (TPM) induce immune response in the peritoneal cavity

Assess whether intra-abdominal pressure is location-dependent

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Intraperitoneal paclitaxel-loaded tumor penetrating microparticles (TPM)Experimental Treatment1 Intervention

Paclitaxel-loaded tumor penetrating microparticles (TPM), dose escalation starting at 50 mg/m\^2 instilled in the peritoneal cavity at study start and again 6-8 weeks after the first TPM treatment.

0 / 18Eligibility criteria met